Gefitinib After Chemotherapy in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
RATIONALE: Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. It is not yet known whether giving gefitinib after initial chemotherapy is effective in delaying the recurrence of non-small cell lung cancer.
PURPOSE: This randomized phase III trial is studying gefitinib to see how well it works compared to placebo in delaying tumor recurrence in patients who have undergone initial chemotherapy for stage IIIB or stage IV non-small cell lung cancer.
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|Official Title:||A Randomized Phase III Study of Follow Up With or Without Adjuvant Gefitinib (Iressa™) Following Chemotherapy in Patients With Advanced Non-Small Cell Lung Cancer|
- Overall survival [ Designated as safety issue: No ]
- Progression-free survival [ Designated as safety issue: No ]
- Toxicity as assessed by CTC [ Designated as safety issue: Yes ]
|Study Start Date:||May 2004|
|Primary Completion Date:||July 2008 (Final data collection date for primary outcome measure)|
- Compare overall survival of patients with stage IIIB or IV non-small cell lung cancer that did not progress on prior first-line palliative induction chemotherapy when treated with adjuvant gefitinib vs placebo.
- Compare progression-free survival of patients treated with these regimens.
- Determine the safety and toxicity of gefitinib in these patients.
OUTLINE: This is a randomized, placebo-controlled, double-blind, multicenter study. Patients are stratified according to initial disease stage (IIIB vs IV), WHO performance status at the end of prior first-line palliative induction chemotherapy (0-1 vs 2), best patient response to prior first-line palliative induction chemotherapy (objective response vs stable disease), and participating center. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral gefitinib once daily.
- Arm II: Patients receive oral placebo once daily. In both arms, treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 598 patients (299 per treatment arm) will be accrued for this study within 8.5 years.
|Ziekenhuis Netwerk Antwerpen Middelheim|
|Antwerpen, Belgium, B-2020|
|Ghent, Belgium, B-9000|
|CHR - Clinique Saint Joseph - Hopital de Warqueguies|
|Mons, Belgium, B-7000|
|Clinique Sainte Elisabeth|
|Namur, Belgium, 5000|
|Bank Of Cyprus Oncology Centre|
|Nicosia, Cyprus, 2006 Strovolos|
|National Cancer Institute of Egypt|
|Ospedali Riuniti di Bergamo|
|Bergamo, Italy, 24100|
|Ospedale Santa Croce|
|Cuneo, Italy, 12100|
|Universita di Ferrara|
|Ferrara, Italy, 44100|
|Presidio Ospedaliero di Livorno|
|Livorno, Italy, 57100|
|Ospedale Niguarda Ca'Granda|
|Milan, Italy, 20162|
|Ospedale Luigi Sacco|
|Milan, Italy, 20157|
|Azienda Ospedaliera - Universitaria di Modena|
|Modena, Italy, 41100|
|Azienda Ospedaliera Maggiore Della Carita|
|Novara, Italy, 28100|
|Azienda Ospedale S. Luigi at University of Torino|
|Orbassano, Italy, 10043|
|Azienda Ospedaliera Policlinico Paolo Giaccone|
|Palermo, Italy, 90127|
|Azienda Ospedaliera Di Parma|
|Parma, Italy, 43100|
|Azienda Ospedaliera "Santa Maria Degli Angeli"|
|Pordenone, Italy, 33170|
|Ospedale Sta. Maria Delle Croci|
|Ravenna, Italy, 48100|
|Arcispedale S. Maria Nuova|
|Reggio Emilia, Italy, 42100|
|Azienda Ospedaliera S. Camillo-Forlanini|
|Rome, Italy, 00152|
|Ospedale di Circolo e Fondazione Macchi|
|Varese, Italy, 21100|
|Ospedale Civile Maggiore - Borgo Trento|
|Verona, Italy, 37126|
|Jeroen Bosch Ziekenhuis|
|'s-Hertogenbosch, Netherlands, 5211 NL|
|Arnhem, Netherlands, 6800 TA|
|Kennemer Gasthuis - Locatie EG|
|Haarlem, Netherlands, 2000|
|Leiden University Medical Center|
|Leiden, Netherlands, 2300 RC|
|St. Franciscus Gasthuis|
|Rotterdam, Netherlands, 3045 PM|
|Study Chair:||Jan P. Van Meerbeeck, MD, PhD||Universitair Ziekenhuis Gent|